Nucala Injection recalled over temperature-control failures

Recall date

September 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cardinal Health dba Specialty Pharmaceutical Services recalls Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactu…

Recall number

D-1876-2019

FDA classification

Class II

Brand / firm

Cardinal Health dba Specialty Pharmaceutical Services

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Temperature Abuse; Product stored and shipped outside of labeled storage requirements.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42.